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  • Testimonials

Real Feedback from Industry Leaders

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Shashank Sharma
Shashank Sharma
Engineer Manager - BSV
”
★★★★★

"Flocon Industries completely transformed our operational efficiency! We used to waste precious water and significant amounts of steam caused by flushing the system manually; Flocon solved this completely. By strategically implementing steam traps at every single user point, they eliminated manual flushing entirely. From their brilliant initial evaluation to flawless implementation, they saved us an incredible amount of time and energy. If you need pharma water system solutions, Flocon is the absolute best!"

Srinivas Kusunuru
Srinivas Kusunuru
MSN Labs
”
★★★★★

Our association with Flocon is defined by three key pillars: Unmatched Reliability: Flocon’s systems have consistently met the rigorous regulatory standards required for our global operations, ensuring seamless uptime and product integrity. Technical Excellence: The depth of engineering expertise within the Flocon team has provided us with customized solutions that address our most complex water-handling challenges. Shared Values: Beyond the hardware, it is the transparency and responsiveness of the Flocon team that makes them a preferred partner. They operate with a customer-first mindset that aligns perfectly with MSN’s own dedication to excellence.

Mural Krishna
Mural Krishna
Essilor Luxottica, Senior Manager Supply Chain
”
★★★★★

FLOCON Industries has been a trusted and reliable partner in supporting our operations with high-quality water systems and engineering solutions. Their strong technical knowledge, expertise, consistency of product performance, and customer-focused approach have added significant value to our manufacturing processes over the years. What stands out most of all is their commitment to quality, responsiveness, and ability to understand evolving operational needs, ensuring seamless integration and long-term reliability. Our continued association with FLOCON Industries is a reflection of confidence and trust they have built through their professionalism and service excellence.

T Prasad
T Prasad
Natco Pharma Ltd
”
★★★★★

"Flocon Industries is one of the most trusted suppliers to Natco Pharma Ltd. Their team demonstrated deep knowledge of pharmaceutical process requirements, especially in PW Generation, PW and WFI Storage & distribution systems. We are satisfied with the overall project outcome."

Walter Gonsalves
Walter Gonsalves
Centaur Pharmaceuticals Pvt. Ltd
”
★★★★★

With reference to the work carried out at our plant, we appreciate the professionalism and technical understanding shown by the Flocon team. Your team completed the project within committed timelines. Flocon Industries consistently maintained high safety and quality standards at our manufacturing site. The speed and workmanship exceeded our expectations.

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  • Faqs

Frequently Asked Questions

Find answers to common questions about our industrial and manufacturing services, processes, and support. If you need more details, our team is always ready to help.

Still Have Questions?

Our experts are here to guide you through every step of your industrial transformation journey.

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Typical information that shall be required are the Facility type, feed water quality (Chemical and Micro), Peak demand per hour, Total demand per day, Utilities available, standards or markets to comply with, installation site, and operational requirements. The more complete the information, the more accurately the system can be sized and priced.

Yes. A high-purity water system like Purified water, water for injection and pure steam can be designed to meet the expectations of both US FDA (21 CFR) and EU GMP Annex 1/Annex 15, provided the system is properly designed, validated, monitored, and maintained. Regulatory acceptance ultimately depends on successful inspection and demonstration that the system consistently produces water meeting the required quality attributes and is operated under a compliant quality management system.

A structured design review process helps ensure the high-purity water (HPW) system meets user requirements, regulatory expectations, and project objectives before fabrication starts. Fabrication should begin only after all critical design documents like P&ID, Tank / vessel drawings, Plant Layout, foundation requirements, interlock schedule for automation and 21CFR reporting tools have been reviewed and formally approved by the client. 

 

The preferred approach is that the client provides the User Requirements Specification (URS) because it defines the operational, quality, and regulatory needs of the facility. However, in practice, many projects require the equipment supplier to assist in developing or refining the URS. Hence Flocon Industries can help its clients to prepare a detailed URS so that the system can be designed as per global compliance standards.

Managing orbital welding and hygienic piping installation for a high-purity water (HPW) system requires a documented quality program that ensures the installed system complies with GMP, hygienic design principles, and project specifications. Flocon Industries ensures its installation team follows its welding SOP’s at site that include  the following points like Approved Welding Procedures, Qualified Personnel, calibrated and tested orbital welding machine, Internal Purging, sample joints etc. 

The typical time required to supply a purified water system is about 8 to 10 weeks from the date of Purchase order. The installation and commissioning timeline at sites are generally another 6-8 weeks depending on the site conditions and approvals. 

 

A comprehensive DQ/IQ/OQ validation package with protocol execution support is intended to demonstrate that the high-purity water system has been designed, installed, and operated in accordance with the approved requirements and applicable GMP expectations. Supporting documents include a number of SOP’s, reports. GA drawings, Isometric drawings, As-built drawings, challenge tests, MOC certificates, Calibration certificates, etc. 

 

Eliminating Manual Hose Cleaning While Ensuring Compliance and Repeatability

Client Challenge: Requirement for a Fully Automatic, Compliant Hose Pipe Cleaning System

A leading pharmaceutical manufacturer approached Flocon Industries with a requirement to automate the cleaning of process transfer hoses used in critical manufacturing operations. The client was relying on manual cleaning methods, where cleaning effectiveness largely depended on operator practices, resulting in inconsistencies and increased compliance risks. The client required a cleaning solution that would consistently deliver validated cleaning performance while complying with stringent pharmaceutical regulatory requirements, including 21 CFR Part 11 and cGMP guidelines. The existing cleaning process presented several operational challenges:

  • Inconsistent cleaning quality due to manual intervention
  • Difficulty in achieving repeatable and validated cleaning cycles
  • Increased risk of cross-contamination between production batches
  • High manpower dependency and longer cleaning turnaround times
  • Limited process monitoring, documentation, and traceability required for regulatory audits

The client required a fully automated system capable of delivering reliable, hygienic, and repeatable hose cleaning while improving operational efficiency and ensuring regulatory compliance.

Flocon Solution: Fully Automatic Hose Pipe Cleaning System

Understanding the critical importance of validated cleaning in pharmaceutical manufacturing, Flocon Industries successfully designed, manufactured, installed, and handed over a Fully Automatic Hose Pipe Cleaning System engineered specifically for regulated production environments. The system automates the complete hose cleaning process, ensuring consistent cleaning performance with minimal operator intervention while maintaining the highest standards of hygiene and compliance.

The solution delivers:

  • Fully automatic cleaning cycles for repeatable and validated performance
  • Consistent high-pressure cleaning for effective removal of process residues
  • Reduced manual handling and minimized operator dependency
  • Improved contamination control through hygienic system design
  • Enhanced operational efficiency with shorter cleaning turnaround times

System Features

To achieve this, the system incorporates:

  • Sanitary SS316/SS316L product contact construction for pharmaceutical applications
  • Hygienic design optimized for maximum cleanability and contamination prevention
  • PLC-HMI based automatic control system with intuitive user interface
  • High-pressure cleaning circuit engineered for reliable and consistent cleaning performance
  • 21 CFR Part 11 compliant automation with electronic data logging and audit trail capabilities
  • cGMP-compliant design suitable for validated pharmaceutical manufacturing facilities

Result

By implementing Flocon’s Fully Automatic Hose Pipe Cleaning System, the client successfully standardized its hose cleaning process, improved cleaning consistency, reduced manual intervention, and strengthened regulatory compliance, resulting in higher productivity, enhanced product protection, and greater confidence in cleaning validation.

Resolved Need For Cooled WFI Without Compromising Quality or Sterility

Client Challenge: Requirement of Instantaneously Cooled WFI at the Point of Use

A leading pharmaceutical manufacturer approached Flocon Industries with a critical process challenge. The client was manufacturing temperature-sensitive products where Water for Injection (WFI) was required at controlled temperatures ranging from 20°C to 30°C. However, the WFI generated and distributed within the facility was maintained at approximately 80–85°C to preserve its microbiological quality. Using hot WFI directly in the manufacturing process posed several risks:
  • Potential degradation of active pharmaceutical ingredients (APIs)
  • Changes in excipient characteristics
  • Adverse impact on product stability
  • Variations in mixing performance and process consistency
The conventional approach adopted by the client involved collecting hot WFI in a storage vessel and allowing it to cool down before use. This process typically required 2 to 4 hours, creating significant operational challenges. Prolonged holding periods exposed the WFI to increased risks of microbial and chemical contamination. Additionally, the extended cooling time led to process delays, reduced manufacturing flexibility, and inefficiencies in production scheduling. The client required a solution that could provide instantaneously cooled WFI at the point of use while maintaining the highest standards of sterility, compliance, and process reliability.

Flocon Solution: ThermoPoint – Engineered for Critical Applications

Understanding that every process challenge demands a unique engineered solution, Flocon Industries developed and supplied ThermoPoint, an advanced Point-of-Use WFI Cooling System. ThermoPoint enables the client to obtain precisely cooled WFI instantly at the point of use, eliminating the need for intermediate storage and prolonged cooling periods. The system ensures:
  • Instantaneous cooling of WFI to the required temperature
  • Preservation of microbiological integrity throughout the process
  • Elimination of contamination risks associated with stagnant storage
  • Enhanced operational efficiency and reduced process downtime

System Features

To achieve this, ThermoPoint incorporates:
  • High-efficiency sanitary heat exchanger for precise temperature control
  • Aseptic diaphragm valves to ensure hygienic operation
  • PLC-HMI based fully automatic controls for consistent and reliable performance
  • Compact cabinet-based plug-and-play configuration for easy integration
  • Complete validation documentation including FAT, DQ, IQ, OQ, and supporting compliance documents

Result

By implementing ThermoPoint, the client successfully achieved safe, hygienic, and on-demand cooling of WFI at the point of use. The solution eliminated prolonged cooling and intermediate storage while improving process efficiency, maintaining product quality, and supporting regulatory compliance.

Ensured Critical Data Storage Integrity And 21 CFR Part 11 Compliance

Client Challenge: Ensuring Data Integrity and Regulatory Compliance in Pharma Water Systems

A pharmaceutical manufacturing facility approached Flocon Industries with a growing compliance concern regarding its Purified Water (PW) and Water for Injection (WFI) systems. The plant was operating using conventional relay-based and PLC-HMI control systems that efficiently generated and distributed water to manufacturing points of use. However, these systems lacked robust mechanisms for secure data storage, traceability, and regulatory compliance. As a result, critical operational and water quality data were not adequately safeguarded, leading to concerns regarding:
  • Reliability and authenticity of water quality records
  • Integrity of historical trend reports
  • Effectiveness of deviation investigations
  • Validity of batch release decisions
  • Regulatory readiness during audits
The client’s Quality Assurance and Quality Control teams required a solution that could ensure complete data integrity while complying with stringent regulatory expectations.

Flocon Solution: SCADA Systems with 21 CFR Part 11 Compliance

Understanding the critical importance of trustworthy electronic records, Flocon Industries engineered a comprehensive automation and data management solution based on advanced SCADA architecture. Flocon’s SCADA platform was specifically designed to meet the requirements of 21 CFR Part 11, ensuring that all electronically generated operational and water quality data remain secure, traceable, and audit-ready. The solution incorporated:
  • Secure electronic data storage and archival
  • Comprehensive audit trails for all critical actions
  • Controlled user access with role-based permissions
  • Electronic signatures for GMP decision-making
  • Real-time and historical trend analysis
  • Complete traceability of process events and system interventions

Result

With Flocon’s SCADA solution, the client achieved 21 CFR Part 11 compliant electronic data management while significantly strengthening data integrity, operational transparency, traceability, and audit preparedness. The solution provided secure and reliable access to critical process data, enabling better decision-making and greater confidence in regulatory compliance.

Controlled Microbial Growth In Purified Water Generation, Storage And Distribution Systems

Client Challenge: Controlling Microbial Growth Across the Entire Purified Water Lifecycle

A pharmaceutical manufacturer was experiencing recurring microbial contamination in its Purified Water (PW) generation and distribution system. While periodic sanitization was effective during the cleaning cycle, microbial growth returned once the disinfectant was neutralized to protect the RO membranes. The surviving microorganisms gradually multiplied, increasing the risk of contamination throughout the system. The contamination was further influenced by multiple sources, including:
  • Upstream PW generation equipment
  • Point-of-use operations
  • Atmospheric exposure
  • Stagnant or low-flow sections within the distribution loop
Over time, these conditions promoted microbial growth and biofilm formation, resulting in:
  • Elevated microbial counts in purified water
  • Batch failures and quality deviations
  • Production downtime and product losses
  • Increased compliance and regulatory risks
The client required a reliable, continuous microbial control solution that could prevent regrowth, maintain water quality, and support GMP compliance without compromising the integrity of the Purified Water system.

Flocon Solution: Maintaining PW Systems Below 25°C for Enhanced Microbial Control

Flocon Industries evaluated the complete water system and recommended a preventive strategy focused on controlling one of the key contributors to microbial proliferation—temperature. Flocon engineered a solution to maintain both the Purified Water generation system after disinfection neutralization and the storage and distribution network at temperatures below 25°C. The solution was achieved through:
  • Chilled water jacket arrangements for storage tanks
  • High-efficiency sanitary heat exchangers
  • Automated temperature monitoring and control systems
By consistently maintaining process fluid temperatures below the defined set point, microbial growth rates were significantly reduced, minimizing the risk of biofilm formation.

Result

The implemented solution provided continuous temperature-based microbial control across the Purified Water system, reducing the risk of microbial regrowth and biofilm formation. The client achieved improved microbiological control, greater system reliability, and a safer, more consistent Purified Water generation, storage, and distribution process while supporting GMP requirements.

Eliminated Microbial Fouling Caused By Pseudomonas In Purified Water Systems

Client Challenge: Eliminating Persistent Pseudomonas Contamination

A pharmaceutical facility approached Flocon Industries after experiencing repeated microbial contamination within its Purified Water system. Despite routine sanitization practices, the system continued to test positive for Pseudomonas aeruginosa—a highly resilient pathogen capable of colonizing both new and existing water systems. The microorganism rapidly formed biofilms inside pipelines, filters, and treatment equipment, creating persistent contamination challenges. The client faced several critical issues:
  • Resistance to conventional chlorine disinfection
  • Progressive fouling of RO membranes and filters
  • Reduced system performance and reliability
  • Increased maintenance requirements
  • Significant risks to product quality and patient safety
The facility required a robust and continuously monitored disinfection strategy capable of eliminating pathogen growth and preventing future recurrence.

Flocon Solution: Chlorine Recirculation and Advanced Ozonation Systems

Recognizing that conventional inline chlorine dosing can result in fluctuating and inconsistent disinfectant levels, Flocon Industries proposed a more controlled approach. Flocon designed and implemented a dedicated Chlorine Recirculation System equipped with online chlorine and ORP monitoring sensors. The system continuously measures and maintains the desired disinfectant concentration throughout the entire water circuit, ensuring effective 24×7 microbial control. For facilities with confirmed pathogenic contamination in feed water, Flocon further integrated advanced Ozonation Systems complete with online ozone monitoring. The combined solution provided:
  • Continuous pathogen suppression
  • Uniform disinfectant concentration throughout the system
  • Reduced risk of biofilm formation
  • Enhanced microbiological safety
  • Improved operational reliability and regulatory compliance

Result

By implementing this engineered approach, the client successfully restored and maintained a controlled and microbiologically safe Purified Water system. Continuous monitoring and controlled disinfection helped reduce the risk of recurring Pseudomonas contamination, biofilm formation, and associated system fouling while improving overall system reliability and compliance.

Resolved Pure Steam Quality Failure At Critical User Points

Client Challenge: Ensuring Pure Steam Quality at Critical User Points

A leading vaccine manufacturing facility in India approached Flocon Industries after repeatedly failing Pure Steam quality tests at critical user points. The facility experienced unacceptable moisture levels in Pure Steam supplied to autoclaves and sterilizers, resulting in non-compliance with required steam quality standards. The existing plant had evolved over several years, resulting in extensive and complex Pure Steam distribution networks. Due to the operational nature of the facility, complete replacement of the piping system was neither practical nor economically feasible. The client faced several critical challenges:
  • Excessive moisture content at Pure Steam user points
  • Extensive and complex piping networks with limited documentation
  • Difficulty in identifying low points, dead legs, and condensate accumulation zones
  • Potential impact on sterilization efficiency and process validation
  • Risk of non-compliance with regulatory Pure Steam quality requirements
The facility required a detailed engineering assessment and a practical retrofit solution capable of restoring Pure Steam quality without disrupting ongoing manufacturing operations.

Flocon Solution: Installation of Sanitary Clean Steam Traps and Moisture Separators

Flocon Industries deployed its engineering team to conduct a comprehensive site assessment of the entire Pure Steam distribution system. The first step involved detailed mapping and preparation of complete isometric drawings of the existing network, comprising two Pure Steam Generators (PSGs) and six distribution headers. Following detailed analysis, Flocon identified critical areas including low-lying sections, dead legs, condensate pockets, and long horizontal piping stretches where condensate accumulation was adversely affecting steam quality. Flocon implemented a series of engineered modifications, including:
  • Installation of sanitary Clean Steam traps at identified condensate accumulation points
  • Elimination and correction of low points and dead legs within the distribution network
  • Installation of Clean Steam moisture separators upstream of autoclaves and sterilizers
  • Optimization of condensate removal throughout the Pure Steam system
The engineered solution provided:
  • Significant reduction in moisture carryover
  • Improved steam dryness fraction at user points
  • Enhanced sterilization performance and process reliability
  • Compliance with Pure Steam quality requirements
  • Improved operational efficiency and regulatory readiness

Result

Following implementation and qualification, the client successfully achieved compliance with Pure Steam quality standards and consistently passed steam quality validation tests at all critical user points. The retrofit solution improved steam dryness, condensate management, and overall system reliability without requiring replacement of the existing distribution network.

Overcame High TOC Values In Traditional DM Plant Systems

Client Challenge: Overcoming High TOC Levels in Conventional DM-Based Purified Water Systems

Before the widespread adoption of hot water sanitizable RO-EDI technology, many pharmaceutical facilities relied on conventional Deionized (DM) water plants comprising Cation, Anion, and Mixed Bed resin systems for Purified Water generation. While these systems consistently achieved acceptable pH and conductivity levels, they frequently struggled to maintain Total Organic Carbon (TOC) within increasingly stringent pharmaceutical specifications. The inability of ion exchange resins to effectively remove dissolved organic contaminants often resulted in elevated or fluctuating TOC levels in the final treated water. This challenge has become even more pronounced in recent years due to rising organic loads in incoming feed water supplies. The client faced several critical issues:
  • Frequent excursions in Purified Water TOC values
  • Inadequate removal of dissolved organic contaminants by resin beds
  • Increasing organic contamination in feed water sources
  • Risk of batch rejection and regulatory non-compliance
  • Need to upgrade water quality without modifying existing qualified DM systems
The facility required a practical and cost-effective solution capable of consistently reducing TOC levels while preserving the existing validated water treatment infrastructure.

Flocon Solution: Installation of Hot Water Sanitizable RO Systems Downstream of Existing DM Plants

Recognizing the limitations of conventional ion exchange technology for TOC removal, Flocon Industries proposed the installation of a Hot Water Sanitizable Reverse Osmosis (RO) system downstream of the existing DM plant. This approach enabled the client to retain the already qualified DM system while significantly enhancing overall water quality performance. Flocon has successfully implemented numerous Hot Water Sanitizable RO systems in pharmaceutical facilities facing similar challenges. The engineered solution offered several advantages:
  • Reduction of TOC levels by up to 90%
  • Consistent compliance with Purified Water TOC specifications
  • High operational recovery rates of up to 90–95%
  • Monthly hot water sanitization capability at 80°C for effective microbial control
  • Improved microbiological and chemical water quality
  • Minimal modifications to existing validated DM infrastructure

Result

By integrating Hot Water Sanitizable RO technology downstream of the existing DM plant, the client achieved reliable TOC control and improved overall water quality performance without disturbing the qualified upstream water treatment system. The solution enhanced system performance, strengthened microbiological and chemical control, and supported continued regulatory compliance.